GUEST CONTRIBUTORS

  • Biocontainment: Understanding Biosafety Levels
    Biocontainment: Understanding Biosafety Levels

    This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.

  • A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities
    A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities

    This article presents a new scale for measuring the risk of compound carryover in shared facilities based on the process capability of a cleaning process that can be used to evaluate the probability of cross-contamination by compounds manufactured in a shared facility or equipment train.

  • What To Do When Your CMO Has To Transfer Your Product To A New Facility
    What To Do When Your CMO Has To Transfer Your Product To A New Facility

    You just received an official notification from your CMO: It is going to remediate the facility in which you have been making a commercial product for six years. Now, you look at your options. You can stay with your current CMO, or you can take this opportunity — forced though it may be — to determine if it is time for a change.

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PHARMA OUTSOURCING WHITE PAPERS

Manufacturing Process Scale-up For Phase III Manufacturing Process Scale-up For Phase III

Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?

Managing Demand Uncertainty In Biologics Production Managing Demand Uncertainty In Biologics Production

How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

Improving Compliance And Manufacturing Efficiency In Life Sciences

Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.

Blinding Clinical Supplies Utilizing Over-Encapsulation
White Paper: Blinding Clinical Supplies Utilizing Over-Encapsulation
A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms

The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.

A World Of Opportunities: Your Focused Field Guide For Specialty Transport To Emerging Markets

What documentation and steps are required to clear a product shipment for entry into China? What is the ability for major airports in Brazil to store refrigerated products while they are awaiting customs clearance?

More From OP White Papers - random

PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Ongoing Collaboration Aims To Accelerate Biosimilar Approval In China

As the global biosimilars market continues to grow, so do the complications. Biopharma companies are facing new challenges to reduce their risk and cost and achieve a faster time-to-market to stay competitive.

Data Solutions For CMOs Working With Sponsor Organizations

CMOs can empower their sponsors or customers to conduct many of these activities on their own products or processes through better data transparency.

Environmental Life Cycle Assessment of Single-Use Technologies

Single-use technologies offer an attractive option for biopharmaceutical manufacturing, but their environmental impact needs be considered.

A 3-Step mAb Purification Processes Using Modern Chromatography Media

As a class of molecules, mAbs exhibit many shared properties, making them well-suited for a platform approach to downstream bioprocessing.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum August 21, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Outsourced Pharma August 22 - 23, 2017
San Diego, CA
How To Establish The Number of Runs Required For Process Validation August 23, 2017
1:00 - 2:00 PM EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
The Impact of "Brexit" On Clinical Research – An Operational Readiness Primer August 24, 2017
1:00 - 2:30 PM EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum August 25, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
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